cobas4800高危型人乳头瘤病毒检测技术在子宫颈癌前病变筛查和细胞学转诊中的应用

Evaluation of cobas 4800 high-risk HPV test as a tool in cervical cancer screening and cytology triage

目的 评价cobas4800高危型人乳头瘤病毒（HPV）检测技术用于细胞学转诊和子宫颈癌前病变筛查的可行性和可靠性。方法670例研究对象来自于参加子宫颈癌筛查或医院门诊健康检查的妇女，均经病理和细胞学诊断。采用cobas4800HPV检测技术和第2代杂交捕获法（HC-2）平行检测子宫颈脱落细胞标本，比较两种方法的一致性；采用HPVPCR检测（HybriBio）和基因测序分型，比较检测HPV16和HPV18的一致性。以病理诊断结果作为金标准，评估cobas4800HPV检测技术和HC-2筛查子宫颈上皮内瘤变（CIN）2级阳性的灵敏度和特异度。结果cobas4800HPV检测技术与HC-2总符合率为89．40％（Kappa=0．778），阳性符合率为86．42％，阴性符合率为91．36％；cohas4800HPV检测技术与HybriBio筛查HPV16总符合率为88．89％（Kappa：0．777），筛查HPV18的符合率为94．94％（Kappa=0．753），阳性符合率分别为98．91％和100．00％，阴性符合率分别为78．41％和94．44％；以基因测序和HybfiBio结果为标准调整，调整后的HPV高危型阳性符合率为100％，阴性符合率为94．42％；HPV16和HPV18阳性符合率均为100％，阴性符合率分别为82．35％和94．44％。cobas4800HPV检测技术筛查CIN2的灵敏度和特异度分别为91．07％和70．97％，而HC-2分别为93．75％和71．33％，差异无统计学意义（P〉0．05）。结论cobas4800HPV检测技术能够有效的检测HPV16、HPV18和其他高危型HPV病毒，有较高的筛查灵敏度和特异度。

Objective To evaluate the feasibility and reliability of cobas 4800 HPV test for cervical cancer screening and cytology referral. Methods cohas 4800 HPV test and hybrid capture 2 （HC-2） were used to detect high risk HPV DNA in 670 specimens of liquid-based cytology collected from three hospitals. The agreement between cobas and HC-2 tests was assessed. HPV PCR detection （ HybriBio ） and gene sequencing were used for genotyping, and the agreement of HPV16 and 18 genotyped by cobas and HybriBio was evaluated. Histological diagnosis was considered as a gold standard to estimate the sensitivity and specificity of cobas vs. HC-2 in detecting CIN2 ＋in cervical lesions. Results The crude agreement between cobas and HC-2 tests was 89.40%, the Kappa value was O. 778, the positive concordance rate was 86.42%, and the negative concordance rate was 91.36%. The crude agreement rates between cobas and HybriBio on HPV16 and 18 were 88. 89% and 94. 94% , the Kappa values were 0. 777 and 0. 753, the positive concordance rates were 98.91% and 100.00% , and the negative concordance rates were 78.41% and 94.44%, respectively. HPV PCR detection （HybriBio） and gene sequencing were considered as adjusted standard： the high risk HPV positive concordance rate was 100% , negative coincidence rate was 94.42% , HPV16 and 18 positive concordance rates were both 100%, and negative concordance rates were 82.35% and 94.44%, respectively. Regarding the detection of CIN2 ＋ , the sensitivity and specificity were 91.07% and 70.97% for cobas, and 93.75% and 71.33% for HC-2, with a non-significant difference between the results of the two tests （P 〉 0.05 ）. Conclusions cobas4800 HPV test has good screening sensitivity and specificity in correct detection of HPV16 and 18 and other high-risk HPV virus types.